The US FDA’s Process Analytical Technology (PAT) initiative provides a structure for “Quality by Design” (QbD) deployment. As part this initiative, knowledge of industrial processes is gained using ...

Continuous processing can get products to market about 12 months faster than batch processing, according to a 2022 paper by the FDA. Understandably, the drive to transition to continuous bioprocessing ...

Although some aspects of process validation for continuous processes are the same as those for traditional batch processes, there are some unique considerations. Although some aspects of process ...

Processes yielding >500 mg plasmid DNA/L have previously been reported by Merck, Boehringer Ingelheim, and Nature Technology (NTC). Common features among these high-yield processes include the use of ...

The requirements of a granule drying process haven?t really changed much in recent years: pharmaceutical companies still need a process/technology that is capable of drying the produced granules as ...

The utilization of online process analytical technology (PAT) has become a high-profile endeavor in the biotechnology industry in recent years. Since the early 1980s, many fermentation scientists have ...

Historically, pharmaceutical products have been produced in a traditional ‘batch’ system, in which every operation is executed separately using a defined quantity of materials. In batch manufacturing ...

Enduro Genetics, a Denmark-based start-up, aims to increase efficiency in biomanufacturing. By getting producing cells ‘addicted’ to production, the start-up aims to vastly improve production ...